This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study of FORTEO Use in Subjects in the Community Setting (NCT01078805), a registered phase not stated study. The primary outcome is Percentage of Participants With Non-Vertebral Fragility Fractures.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01078805 |
| Phase | Phase not stated |
| Condition | Osteoporosis |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 4167 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants with osteoporosis who received at least one dose of study drug, had non-missing start and stop dates, and did not discontinue study drug for more than 3 consecutive months at one time during the treatment phase. These are the eligibility conditions stated for the primary outcome population.
Intervention
FORTEO (teriparatide), recorded as a drug intervention. The registry describes a FORTEO-treated group.
Comparator
A like-for-like control comparison is not reported. The registry record does not state allocation, and the available description is not a randomized comparison.
Primary question
Among the specified treated population, what percentage had a new non-vertebral fragility fracture up to 24 months? The registry defines these fractures as low-trauma fractures, such as a fall from standing height. The primary outcome result is not reported in the registry record.
The study’s stated purpose was to evaluate long-term effectiveness, safety, and tolerability of FORTEO in a larger, more diverse community population than those studied in clinical trials. The primary question is descriptive: it concerns the proportion of the specified population with a new fracture during the stated period. Without a reported outcome estimate, the registry record does not establish the observed frequency of fractures in that population.
3. Trial Design
DANCE, with the official title Direct Assessment of Non-Vertebral Fractures in Community Experience, is a study of FORTEO use in the community setting. The registry lists osteoporosis as the condition, Eli Lilly and Company as the sponsor, and FORTEO as the drug intervention. The study status is completed. The recorded enrollment is 4167.
The registry gives a start date of 2003-08 and a primary completion date of 2011-02. These dates describe the recorded study timeline; they do not, by themselves, establish how long individual participants were followed. The primary outcome timeframe is up to 24 months.
The described treatment group is FORTEO-treated. The registry does not state allocation, and the record does not describe a randomized comparison or a like-for-like control group. Consequently, the available description does not support interpreting the study as a randomized treatment-versus-control comparison. The number of participants in the primary outcome analysis population is not reported in the registry record.
The primary outcome is the percentage of participants with non-vertebral fragility fractures. The record also lists secondary outcomes covering clinical vertebral fractures, pain scores, treatment adherence, bone mineral density, bone mineral content, bone area, and physician criteria for initiating FORTEO therapy. The registry lists nine outcome measures and eight analyses, but does not report the results of the primary outcome or provide enough detail to reconstruct its analysis.
The study’s stated aim gives the community setting particular relevance: it sought to assess use in a population described as larger and more diverse than populations studied in clinical trials. That stated aim is not evidence that the enrolled participants represented any particular demographic or clinical range. Details of participant characteristics and recruitment are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | FORTEO (Teriparatide)-Treated |
|---|---|
| STARTED | 4167 |
| Took at Least 1 Dose of Study Drug | 4085 |
| Modified Intent-To-Treat | 3720 |
| COMPLETED | 2117 |
| NOT COMPLETED | 2050 |
Reasons for not completing this period:
| Reason | FORTEO (Teriparatide)-Treated |
|---|---|
| Clinically significant abnormal lab | 5 |
| Death | 134 |
| Lost to Follow-up | 676 |
| Physician Decision | 169 |
| Serious adverse event | 26 |
| Sponsor decision | 46 |
| Withdrawal by Subject | 739 |
| Other | 173 |
| Didn't take study drug | 82 |
Analysis population for the primary outcome, as defined in the registry: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | FORTEO (Teriparatide)-Treated |
|---|---|---|
| Participants analysed | 3720 | |
| Age Continuous | years | 67.96 (SD 11.72) |
| Sex/Gender, Customized: Female | participants | 3350 |
| Sex/Gender, Customized: Male | participants | 369 |
| Sex/Gender, Customized: Unknown | participants | 1 |
| Race/Ethnicity, Customized: African | participants | 57 |
| Race/Ethnicity, Customized: Asian | participants | 11 |
| Race/Ethnicity, Customized: Caucasian | participants | 3282 |
| Race/Ethnicity, Customized: East Asian | participants | 29 |
| Race/Ethnicity, Customized: Hispanic | participants | 321 |
| Race/Ethnicity, Customized: Other | participants | 18 |
| Race/Ethnicity, Customized: Unknown | participants | 2 |
| Region of Enrollment: United States | participants | 3720 |
| Physician Criteria for Initiating FORTEO Therapy: New osteoporotic fracture | participants | 848 |
| Physician Criteria for Initiating FORTEO Therapy: Multiple fracture risk factors - per investigator | participants | 3395 |
| Physician Criteria for Initiating FORTEO Therapy: Inadequate response to previous therapy | participants | 2261 |
| Physician Criteria for Initiating FORTEO Therapy: Participant met Forteo threshold -per investigator | participants | 2215 |
| Physician Criteria for Initiating FORTEO Therapy: Intolerance to previous osteoporosis therapy | participants | 891 |
| Physician Criteria for Initiating FORTEO Therapy: Adequate insurance coverage | participants | 925 |
| Physician Criteria for Initiating FORTEO Therapy: Absence of prior authorization criteria | participants | 193 |
| Physician Criteria for Initiating FORTEO Therapy: Participant request | participants | 247 |
| Physician Criteria for Initiating FORTEO Therapy: Height loss | participants | 697 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Non-Vertebral Fragility Fractures, measured over up to 24 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with a new non-vertebral fragility fracture up to 24 months. The registry defines a non-vertebral fragility fracture as a low-trauma fracture, with a fall from standing height given as an example. It describes the outcome as binary: a participant either had a new fracture or did not.
For this endpoint, the percentage is defined as the number of participants with a new non-vertebral fragility fracture divided by the number of participants at risk, multiplied by 100. The registry’s stated primary population includes participants who received at least one dose of study drug, had non-missing start and stop dates, and did not discontinue study drug for more than 3 consecutive months at one time during the treatment phase. The number at risk and the number with a fracture are not reported in the registry record, so the percentage cannot be described from the available record.
A fracture endpoint is clinically interpretable because it records an event rather than a change in a laboratory or imaging measure. In general, a proportion provides a direct description of how often an event occurred in a defined population and period. It does not, on its own, show whether treatment caused a change in event frequency. That distinction is especially important when a suitable comparison group and an adjusted analysis are not reported.
The listed secondary outcomes include clinical vertebral fractures and several pain and bone measures. Those outcomes address different aspects of health and treatment experience; they are not substitutes for the primary fracture outcome. Their results are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clear primary outcome and defines the population for its assessment, but it does not report the primary outcome result. In particular, it does not state how many participants in the analysis population had a new non-vertebral fragility fracture, how many were at risk, or the resulting percentage. There is therefore no reported primary estimate to interpret for magnitude or precision.
The enrollment of 4167 describes the recorded study enrollment, not necessarily the denominator for the primary outcome. The primary analysis population has additional stated conditions: participants needed to have received at least one dose, have non-missing start and stop dates, and avoid a treatment discontinuation lasting more than 3 consecutive months at one time. The size of that population is not reported in the registry record. It would not be appropriate to substitute overall enrollment for the endpoint denominator.
The record does not report a control group suitable for a like-for-like comparison, and it does not state allocation. The study is therefore not described as a randomized comparison. An observed proportion in the treated group, even if available, would describe outcomes in that group; without a suitable comparison and analysis, it would not by itself quantify the causal effect of FORTEO. Differences in participant characteristics, care, and follow-up could matter in any comparison with other populations or studies.
Precision also cannot be assessed for the primary endpoint. A confidence interval would ordinarily communicate the range of values compatible with an estimate under the statistical model, but neither an estimate nor an interval is reported in the registry record. The same limitation applies to inferential results: no primary-outcome p-value, test, or adjusted estimate is reported. No conclusion about statistical significance or uncertainty around the primary result can be drawn from the registry information.
The registry lists secondary outcomes, including clinical vertebral fractures, pain scores, adherence, bone measures, and physician criteria. The existence of multiple outcomes raises a general interpretive issue: when many outcomes are examined, chance findings can become more likely unless the analysis plan accounts for multiplicity. Whether any adjustment or hierarchy was planned or used is not reported in the registry record. The results of the listed secondary outcomes are also not reported in the record.
Accordingly, the available information describes the study’s purpose, setting, endpoint definition, and eligibility conditions, rather than the observed primary outcome. The study’s stated aim was to evaluate long-term effectiveness, safety, and tolerability in a community population. That aim should not be mistaken for a reported finding about effectiveness, safety, or tolerability. The registry information does not establish whether the observed fracture frequency was high or low, nor how precisely it was estimated.
9. Statistical Methods Explained
The registry describes the primary endpoint as a binary outcome expressed as a percentage: each eligible participant either had a new non-vertebral fragility fracture or did not. The percentage is defined using the number of participants with a new fracture and the number at risk. This definition makes the denominator central to interpretation. Enrollment and the endpoint’s at-risk population are not interchangeable, and the registry does not report the primary analysis denominator or event count.
What does a confidence interval describe?
In general, a confidence interval expresses statistical uncertainty around an estimated quantity. For a proportion, it indicates a range of values that are reasonably compatible with the observed data and the method used to calculate the interval. A narrow interval suggests greater precision than a wide interval, but neither width nor location can be interpreted without the estimate and interval. The primary outcome estimate and its confidence interval are not reported in the registry record.
For a binary outcome, the statistical method should reflect how the data were collected and what population the estimate is meant to describe. A simple proportion is a descriptive summary. A model-based estimate may account for additional features of the study, but the registry record does not report the primary analysis method, any covariate adjustment, or a statistical model. It is therefore not possible to determine whether the posted outcome was analyzed as a simple proportion or through a more complex approach.
Why does the denominator matter?
The primary outcome definition refers to participants at risk, while the population description specifies receipt of at least one dose, non-missing start and stop dates, and limits on treatment discontinuation. These conditions define who was eligible for the primary outcome analysis as described in the record. They do not supply the actual number analyzed, explain how participants contributed follow-up time, or describe handling of participants whose fracture status was unknown. Those details are not reported in the registry record.
In general, incomplete outcome information can affect an estimate if participants with missing data differ from those with observed data. Statistical approaches may use complete observations, model missingness, or apply other methods, but the choice depends on the data and assumptions. The registry record does not report the extent of missing primary outcome data or the method used to address it. No assumptions about missingness should therefore be attributed to this study.
What can be inferred from a one-group description?
General statistical interpretation distinguishes description from causal comparison. A proportion in a treated group describes the frequency of an event in that group over the stated period. Estimating a treatment effect requires a meaningful comparison and assumptions or design features that support attributing differences to treatment. The registry does not state allocation and does not describe a like-for-like control comparison. An outcome proportion, even if reported, would not on its own establish what would have happened to the same population without treatment.
The registry’s planning assumptions describe a separate sample-size illustration: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a stated fraction of the observed effect. The record explicitly distinguishes this illustration from the trial’s own design. It is not evidence that the study was planned using those assumptions, and it is not observed power. The observed primary effect needed to interpret the illustration is not reported in the registry record.
In general, sample-size calculations are conditional on the assumed effect, variability, allocation, and analysis method. They describe planning under those assumptions; they do not establish the probability that a particular observed result is true. For a time-to-event outcome, planning methods can be framed around the total number of events, whereas other outcomes can use participants per arm. The primary endpoint is described as a binary percentage, and the record’s planning note distinguishes these types of illustrations. The trial’s own sample-size justification is not reported in the registry record.
How should multiple outcomes be considered?
The registry lists secondary outcomes in addition to the primary fracture endpoint. In general, examining multiple outcomes creates a multiplicity issue: the more statistical questions considered, the greater the chance that some results may appear noteworthy by chance alone. Prespecified priorities, adjustment methods, or a testing hierarchy can help clarify interpretation. Whether such procedures were planned or used is not reported in the registry record. The number of listed outcome measures and analyses does not, by itself, reveal which method was used or whether any result was confirmatory.
Over-dispersion is a general concern when observed variability exceeds what a statistical model assumes. It can make standard errors too small and uncertainty appear less than it is if the model is not appropriate. Whether over-dispersion is relevant depends on the outcome structure and analysis. The registry does not report a model or diagnostic assessment for the primary endpoint, so no claim about over-dispersion in this study is warranted.
Overall, the registry provides a clinical definition and a population description for the primary endpoint, but not the numerical result, uncertainty interval, or analysis details required to evaluate the statistical estimate. General explanations of proportions, confidence intervals, missing data, multiplicity, and planning assumptions help frame what those details would mean; they do not fill in unreported study findings.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome and secondary outcomes covering clinical vertebral fractures, back pain, pain, adherence, bone mineral density, bone mineral content, bone area, and physician criteria for initiating FORTEO therapy. It lists nine outcome measures and eight analyses. Multiple outcomes can create a multiplicity concern because repeated statistical testing increases the opportunity for chance findings. Whether the study used an adjustment, a prespecified testing order, or another strategy to address multiplicity is not reported in the registry record. The listed outcomes alone do not establish which analyses were primary, confirmatory, or exploratory beyond the endpoint identified as primary.
The primary population description requires non-missing start and stop dates and sets a condition on treatment discontinuation. This is not a complete account of missing outcome data. The registry record does not report how many participants had missing fracture status, why data might be missing, or how missing outcome information was handled. It also does not report whether any sensitivity analyses assessed the effect of missing data.
The described analysis population is restricted to participants who received at least one dose and met the stated date and treatment-discontinuation conditions. The record does not report the number who met those conditions or explain whether the primary analysis included any other participants. It does not describe an intention-to-treat population or a per-protocol analysis. These analysis-population details matter because results can depend on which participants are included and how follow-up is handled.
Without reported missing-data methods, analysis-population counts, and multiplicity procedures, the robustness of any primary or secondary finding cannot be assessed from the registry record. The primary outcome result itself is not reported.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| FORTEO (Teriparatide)-Treated | 432 | 4085 | 10.6% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| FORTEO (Teriparatide)-Treated | 0 of 0 |
Most frequent serious adverse event terms
| Event term | Organ system | FORTEO (Teriparatide)-Treated |
|---|---|---|
| Fall | Injury, poisoning and procedural complications | 38 of 4085 |
| Pneumonia | Infections and infestations | 37 of 4085 |
| Hip fracture | Injury, poisoning and procedural complications | 22 of 4085 |
| Myocardial infarction | Cardiac disorders | 18 of 4085 |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 16 of 4085 |
| Death | General disorders | 15 of 4085 |
| Small intestinal obstruction | Gastrointestinal disorders | 14 of 4085 |
| Urinary tract infection | Infections and infestations | 13 of 4085 |
| Cerebrovascular accident | Nervous system disorders | 12 of 4085 |
| Atrial fibrillation | Cardiac disorders | 11 of 4085 |
Serious events with the highest arm-level rate: fall (0.9%), pneumonia (0.9%), hip fracture (0.5%), myocardial infarction (0.4%), chronic obstructive pulmonary disease (0.4%).
The registry records a FORTEO-treated group with 4085 participants at risk for serious adverse events and 432 affected, as listed in the adverse-event information. These are recorded counts; no percentage for this group is calculated. The registry also lists Fall and Pneumonia at 0.9% each, Hip fracture at 0.5%, Myocardial infarction and Chronic obstructive pulmonary disease at 0.4% each, and Death at 0.4% among the top serious terms.
These figures should be read as safety descriptions from the registry, not as a comparison with an untreated or control group. The record does not provide a like-for-like control comparison or the information needed to estimate a treatment-attributable risk. The listed term percentages do not establish that an event was caused by FORTEO, and the registry information does not clarify the calculation denominator for each listed percentage.
Death appears among the listed serious terms, but a separate death count is not reported in the registry record. Serious adverse-event counts and term percentages describe different summaries; they should not be combined or treated as interchangeable. The available figures do not establish comparative safety or the overall balance of benefit and harm.
12. What the Result Does, and Does Not, Mean
The registry record establishes that DANCE was a completed community-setting study of FORTEO and identifies non-vertebral fragility fractures up to 24 months as its primary outcome. It also defines the primary analysis population and describes the study’s intended focus on long-term effectiveness, safety, and tolerability in a larger, more diverse population than those studied in clinical trials. These details help readers understand the question and population the study was intended to address.
The record does not report the primary outcome estimate, event count, or denominator. It therefore does not show the observed percentage of participants with a new non-vertebral fragility fracture. Nor does it provide an interval or other uncertainty measure for that endpoint. Without those results, the frequency and precision of the primary outcome cannot be evaluated.
The study description does not report a like-for-like control comparison, and allocation is not stated. General statistical interpretation distinguishes an observed event frequency in a treated group from a causal treatment effect. Even a fully reported single-group proportion would describe what occurred in that group; it would not, on its own, show what would have occurred without treatment. The registry information therefore does not establish that FORTEO caused a change in fracture frequency.
The record lists serious adverse-event counts and selected event-term percentages, but those figures are not a comparative safety analysis. They do not establish whether an event was attributable to treatment or how event frequency compares with another group. Similarly, the listed secondary outcomes do not constitute reported findings when their results are absent from the registry record.
The study’s stated community-setting aim is relevant to the kinds of questions it sought to address, but it does not establish the representativeness of the participants or the applicability of findings to any particular population. The defensible interpretation is limited to what the record documents: the study purpose, endpoint definitions, population conditions, and selected safety figures. Claims about the magnitude, precision, or causal meaning of the primary result are not supported by the results reported in the registry record.
13. Why This Trial Matters Statistically
DANCE is statistically notable for framing a fracture outcome in a community-setting study rather than describing only a controlled comparison. The registry’s stated purpose was to evaluate long-term effectiveness, safety, and tolerability in a larger, more diverse population than those studied in clinical trials. That aim highlights a general challenge in clinical research: results from a particular study population may not answer every question about treatment use in broader practice.
The primary endpoint is clinically concrete and explicitly defined as a binary event over a stated timeframe. The registry also specifies conditions for the primary analysis population. Together, these details make clear that interpretation depends on more than the overall enrollment: the relevant denominator is the population that met the endpoint-specific conditions and was at risk. The record does not give that denominator or the event count, underscoring why endpoint definitions alone cannot replace outcome reporting.
The study also illustrates the distinction between documenting treatment experience and estimating a comparative treatment effect. The registry describes a treated group and does not state allocation or a suitable control comparison. A group-level event frequency can be informative as a description, but causal interpretation requires an appropriate comparison and adequate analysis. Those features cannot be assumed from the study’s aim or setting.
Finally, the listed secondary outcomes and serious adverse-event terms show why a complete statistical account matters. Readers need results, denominators, uncertainty estimates, analysis-population details, and information about missing data and multiplicity to judge how strongly findings support a conclusion. The registry record identifies several of these questions but does not report the primary outcome result or many of the methods needed to resolve them.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main trial-specific limitation in the registry record is the absence of the primary outcome result. Although the endpoint and population conditions are described, the number at risk, number with a new fracture, estimated percentage, and uncertainty measure are not reported. The primary question therefore cannot be answered from the results recorded.
The registry describes a FORTEO-treated group and does not state allocation or a like-for-like control comparison. This limits causal interpretation: the available study description cannot establish how fracture frequency would compare under another treatment or without treatment. The number of participants who met the primary population criteria is also not reported, so overall enrollment cannot be used as a substitute for the endpoint denominator.
The stated aim refers to a larger, more diverse community population, but the record does not report participant characteristics that would allow readers to assess diversity, representativeness, or applicability to particular groups. Details of recruitment, clinical setting, and follow-up completion are not reported in the registry record. The study timeline and the primary outcome timeframe do not establish individual participants’ actual follow-up duration.
Important statistical details are also not reported: the primary analysis method, treatment of missing outcome information, any covariate adjustment, and procedures for addressing multiple outcomes. The registry lists secondary outcomes but does not report their results. The safety information provides selected serious-event counts and terms, but does not provide a suitable control comparison or enough detail to attribute events to treatment.
These limitations do not establish that the study was poorly conducted; they describe what cannot be evaluated from the registry record. They constrain conclusions about outcome frequency, precision, comparative effects, safety, and generalizability.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of FORTEO Use in Subjects in the Community Setting — NCT01078805.
- Registry record last updated 2012-06-26; status last verified 2012-05.
- Results first posted 2012-06-26.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
DANCE (NCT01078805), officially titled Direct Assessment of Non-Vertebral Fractures in Community Experience, is a completed study of FORTEO use in the community setting. The registry lists Eli Lilly and Company as sponsor, osteoporosis as the condition, and enrollment of 4167. The recorded study dates are 2003-08 and 2011-02 for start and primary completion.
The primary outcome is the percentage of participants with non-vertebral fragility fractures up to 24 months. The registry defines the endpoint and describes eligibility conditions for its analysis population, but does not report the primary outcome result, denominator, or uncertainty estimate. Allocation is not stated, and the record does not describe a randomized, like-for-like control comparison.
Secondary outcomes include fracture, pain, adherence, bone-measure, and physician-criteria measures. The registry also lists serious adverse-event counts and selected serious-event terms. These details do not provide a comparative treatment-effect analysis. Key information on the primary result, missing data, and statistical methods is not reported in the registry record.